INSULIN LISPRO Recall D-0575-2023
Description: Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
INSULIN LISPRO Recall D-0575-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0575-2023 |
| Event ID | 92074 |
| Brand | ADMELOG |
| Generic Name | INSULIN LISPRO |
| Manufacturer | INSULIN LISPRO |
| Original Package? | 1 |
| Active Substance | INSULIN LISPRO |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 51,325 vials |
| Recall Reason | Lack of Assurance of Sterility: Malformed crimped collar seal |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 0024-5924 0024-5925 0024-5926 |
| Product NUI | N0000004931 N0000175453 |
| Pharma Class (EPC) | Insulin Analog [EPC] |
| Pharma Class (CS) | Insulin [Chemical/Ingredient] |
| Recall Initiation Date | 20230411 |
| Report Date | 20230524 |
| Classification Date | 20230515 |
| Address | 55 Corporate Dr Bridgewater, NJ 08807-1265 United States |
| Recalling Firm | Sanofi-Aventis U.S. LLC |
| Initial Notification | |
| Unique Ingredient Identifier | GFX7QIS1II |
| Drug Application Number | BLA209196 |
| Structured Product Labeling (SPL ID) | a9ff7a53-ba49-484d-9b03-7654ef04dabf |
| Structured Product Labeling (SPL Set ID) | 0691def8-4a7b-4de3-866f-a280989f47f1 |
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